Archive for May 6th, 2009

Working a patent for regulatory approvals

Wednesday, May 6th, 2009
Patently-O considers a new Federal Circuit case in the USA dealing with the scope of s 271(e)(1) - a defence to infringement by working the patent to prepare regulatory data. It would appear that the defence should now apply in proceedings against imports before the ITC. Patents Act 1990 (Cth) s 119A (introduced with effect from 25 October 2006 following ACIP's report) permits such activity where the working:
  • is for purposes of having a therapeutic pharmaceutical product included in the Australian Register of Therapeutic Goods;
  • or a similar foreign regulatory approval.
Although working for a foreign regulatory approval may take place only in the supplementary protection period (see e.g. ACIP on experimental use p. 44 (pdf)). See now Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559 at [643]ff. IP Australia is considering extending this: see paragraphs 9 and 17 of IP Australia's Consultation Paper on experimental use (pdf) [NOTE: submissions should be in by 8 May 2009. Submissions on the Getting the Balance Right paper (pdf) are also due by then.] WIPO's Standing Committee on Patents has a study paper on exceptions and limitations as an area of increased focus.

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Patents, pharmaceuticals and exports

Wednesday, May 6th, 2009
I'm not quite sure why, but the blogosphere is increasingly chattering again about relaxing the rules against infringing a patent by making the protected product (esp. a pharmaceutical) for export: IP's What's Up reviews the TRIPS status including the DOHA declaration and its rather tentative take up.

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